This small laboratory has a floor space of 60 m2. It is staffed by one analyst, 2 technicians, and 1-2 housekeeping staff.
Such a laboratory cannot be effectively maintained as an independent unit. It should be incorporated within another governmental laboratory or be sited within a large regional hospital. This provides access to existing technical and library facilities, utilities, and supply arrangements. It is important, none the less, that the manager should remain organizationally independent in the execution of his duties, and that the laboratory should be accorded an independent budget.
It is estimated that such a laboratory could undertake annually 200-300 full analyses (samples fully tested and evaluated in accordance with quality specifications) or a greater number of partial analyses.
The analyst, who should have a proven ability to work independently, should be university trained in pharmacy or chemistry and should have received practical training in an established drug quality control laboratory for 6 months to two years, as determined by background experience. An institutional training for technicians is desirable in addition to in-service training in the laboratory.
The laboratory premises should be provided with basic utilities (water, drainage, and electricity) and equipped with a hot-water source, a distilled-water still, and a propane gas tank, if a piped gas supply is not available. If the laboratory is to be located in a newly erected building it is best constructed as a basic module that may be subsequently extended.
The laboratory furniture, which should be arranged to provide an efficient but uncongested working space, must include: one double chemical bench with two lateral sinks located in the centre of the module, a fume hood, one laboratory bench for instruments, a table for balances, one storage cabinet for solvents, one refrigerator (with freezer compartment), wall shelves, and writing desk. The bench for instruments and the table for balances are positioned in a separate part of the module to protect the instruments from corrosion.
Important items of laboratory equipment are given in Table 1. No listing of reagents or glassware is provided as such lists are best compiled within the laboratory. Provision should always be made for an adequate reserve of glassware and sundry items. This is of particular importance where difficulties in delivery are anticipated.
Table 1. First-stage laboratory for drug surveillance
Equipment and major instruments |
No. |
Analytical balance (four place, mechanical) |
1 |
Spectrophotometer (UV/visible, single-beam, manual) |
1 |
pH-meter (with electrodes) |
1 |
Karl-Fischer titrator |
1 |
Melting-point apparatus |
1 |
Polarimeter (manual) |
1 |
Drying oven |
1 |
Vacuum oven |
1 |
Vacuum pump |
1 |
Centrifuge (table-top) |
1 |
Hot plate with stirrer |
3 |
Equipment for thin-layer chromatography including: |
|
| |
- spreader |
1 |
| |
- spotting equipment |
1 |
| |
- developing chambers |
6 |
| |
- spraying bottles |
6 |
| |
- UV viewing lamp |
1 |
Disintegration test equipment |
1 |
Microscope |
1 |
Refrigerator (with freezer compartment) |
1 |
Micrometer calipers |
1 |
| |
|
Optional items |
|
| |
|
Flame photometer |
1 |
Osmometer |
1 |
Vortex mixer |
1 |
Constant temperature water-bath |
1 |
Ultrasonic cleaner |
1 |
Refractometer |
1 |
Shaker (wrist-action) |
1 |
Oxygen flask combustion apparatus |
1 |